Food Type and Physical Activity Influence on Gastric Emptying Time Assessed by Ultrasound in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Time to ultrasonographic signs of an empty stomach
研究概览
简要总结
Gastric content is a key risk factor for aspiration during anesthesia. Although standard fasting times are recommended, various factors-including GLP-1 receptor agonists,-can delay gastric emptying. Gastric ultrasound enables real-time, non-invasive assessment of gastric volume and can help tailor perioperative management. The aim of this study explores the effects of different meal types and physical activity on gastric emptying in healthy individuals.
详细描述
Pulmonary aspiration of gastric contents is a serious and potentially life-threatening complication of anesthesia. Despite adherence to preoperative fasting guidelines issued by the American Society of Anesthesiologists (ASA), certain medical conditions-such as diabetes mellitus-or medications like GLP-1 receptor agonists may significantly delay gastric emptying beyond standard expectations. This creates a need for individualized assessment of gastric contents prior to anesthesia, especially in patients considered at increased risk.
Gastric ultrasound is a non-invasive, point-of-care technique that allows for real-time assessment of gastric volume and content. It may provide a more reliable indicator of aspiration risk than fasting time alone.
This randomized, prospective study aims to evaluate the effects of different types of meals and physical activity levels on gastric emptying time in healthy adult volunteers, using ultrasound-based measurement of the gastric antrum.
Sixty participants aged 18-40 years will be recruited via registration forms provided by the study team. Each participant will provide written informed consent, including acknowledgment of potential food allergens present in the study meals. The day prior to each session, participants will receive a phone call to remind them of dietary restrictions: no clear liquids for 2 hours, no solid foods for 6 hours, and no fatty meals for 8 hours before the study.
Each participant will take part in two separate sessions, conducted on different days. On both days, the participant will arrive fasting and undergo a baseline gastric ultrasound to confirm an empty stomach. If gastric content is detected, the session will be rescheduled.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 40 years
- •Ability and willingness to provide written informed consent
- •Agreement to comply with study procedures, including pre-study dietary restrictions
- •No history of gastrointestinal disease
- •No recent abdominal surgery
排除标准
- •Lack of informed consent
- •Allergy or intolerance to any of the foods used in the study meals
- •Medical conditions known to delay gastric emptying, including:
- •Obesity (BMI > 30 kg/m²)
- •Diabetes mellitus
- •Gastroesophageal reflux disease (GERD)
- •Hiatal hernia
- •Bowel obstruction
- •Tube feeding
- •Active gastrointestinal disease
- •History of gastrointestinal surgery
- •Current pregnancy or breastfeeding
- •Use of medications affecting gastric motility (e.g., opioids, anticholinergics, GLP-1 receptor agonists)
- •Neuromuscular disorders impairing ability to remain in supine position for 6 hours or to walk for 30 minutes
研究组 & 干预措施
Gastric Ultrasound in Participants Consuming Different Meal Types with Physical Acivity
Participants assigned to this arm will undergo an initial gastric ultrasound to confirm fasting status. They will then consume one of three types of meals: vegetable-based, meat-based, or dairy-based. A gastric ultrasound will be performed 15 minutes after meal ingestion. This will be followed by standardized physical activity (walking a predefined distance). Subsequent gastric ultrasound assessments will be performed at 3 hours and 6 hours post-meal, each followed by the same standardized physical activity. The purpose is to evaluate the impact of food type and intermittent physical activity on gastric emptying, as assessed by ultrasound.
干预措施: Physical activity after different type of meals (Behavioral)
Gastric Ultrasound in Participants Consuming Different Meal Types with Subsequent Rest
Participants in this arm will first undergo a baseline gastric ultrasound to confirm fasting status. They will then consume one of three types of meals: vegetable-based, meat-based, or dairy-based. Gastric ultrasound will be performed 15 minutes after meal ingestion. Unlike the other arm, participants in this group will remain at rest throughout the study period and will not perform any physical activity. Additional gastric ultrasound assessments will be performed at 3 hours and 6 hours post-meal, with participants remaining sedentary between each measurement. This arm will serve to assess the isolated effect of food type on gastric emptying over time without the influence of physical activity.
结局指标
主要结局
Time to ultrasonographic signs of an empty stomach
时间窗: after 15 minutes, 3 hours and 6 hours post-meal
Time (in hours) required to reach a gastric ultrasound profile consistent with an empty stomach (defined individually based on baseline fasting scan), depending on physical activity and meal type
次要结局
- Antral cross-sectional area (CSA)(at 15 minutes, 3 hours, and 6 hours post-meal)
- Estimated gastric volume (GV)(At 15 minutes, 3 hours, and 6 hours post-meal)